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Modified Immune Cells (Autologous CAR T Cells) in Treating Patients With Advanced, Recurrent Platinum Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer

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ClinicalTrials.gov Identifier: NCT03907527
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : August 14, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Precigen, Inc
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

Tracking Information
First Submitted Date  ICMJE April 5, 2019
First Posted Date  ICMJE April 9, 2019
Last Update Posted Date August 14, 2019
Actual Study Start Date  ICMJE April 30, 2019
Estimated Primary Completion Date April 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2019)
  • Incidence of adverse events [ Time Frame: Up to 12 months after infusion ]
    Toxicity grading will be evaluated according to the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version 5.0 and monitoring of adverse events
  • Maximal tolerated dose of PRGN-3005 [ Time Frame: Up to 28 days ]
    Will be determined by a 3 X 3 dose escalation study for both intraperitoneal infusion and intravenous infusion of the trial.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03907527 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2019)
Evidence of anti-tumor activity [ Time Frame: Up to 5 years ]
Graded according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Modified Immune Cells (Autologous CAR T Cells) in Treating Patients With Advanced, Recurrent Platinum Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Official Title  ICMJE Phase I Study Evaluating Benefit of PRGN-3005 UltraCAR-T™ (Autologous CAR T Cells) in Advanced Stage Platinum Resistant Ovarian Cancer Patients
Brief Summary This is a phase I dose escalation study to identify the best dose and side effects of modified immune cells PRGN-3005 (autologous chimeric antigen receptor (CAR) T cells developed by Precigen, Inc) in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has spread to other places in the body, that has come back, and is resistant to platinum chemotherapy. Autologous CAR T cells are modified immune cells that have been engineered in the laboratory to specifically target a protein found on tumor cells and kill them.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Platinum-Resistant Fallopian Tube Carcinoma
  • Platinum-Resistant Ovarian Carcinoma
  • Platinum-Resistant Primary Peritoneal Carcinoma
  • Progressive Disease
  • Recurrent Fallopian Tube Carcinoma
  • Recurrent Ovarian Carcinoma
  • Recurrent Primary Peritoneal Carcinoma
  • Refractory Fallopian Tube Carcinoma
  • Refractory Ovarian Carcinoma
  • Refractory Primary Peritoneal Carcinoma
  • Stage III Fallopian Tube Cancer AJCC v8
  • Stage III Ovarian Cancer AJCC v8
  • Stage III Primary Peritoneal Cancer AJCC v8
  • Stage IIIA Fallopian Tube Cancer AJCC v8
  • Stage IIIA Ovarian Cancer AJCC v8
  • Stage IIIA Primary Peritoneal Cancer AJCC v8
  • Stage IIIA1 Fallopian Tube Cancer AJCC v8
  • Stage IIIA1 Ovarian Cancer AJCC v8
  • Stage IIIA2 Fallopian Tube Cancer AJCC v8
  • Stage IIIA2 Ovarian Cancer AJCC v8
  • Stage IIIB Fallopian Tube Cancer AJCC v8
  • Stage IIIB Ovarian Cancer AJCC v8
  • Stage IIIB Primary Peritoneal Cancer AJCC v8
  • Stage IIIC Fallopian Tube Cancer AJCC v8
  • Stage IIIC Ovarian Cancer AJCC v8
  • Stage IIIC Primary Peritoneal Cancer AJCC v8
  • Stage IV Fallopian Tube Cancer AJCC v8
  • Stage IV Ovarian Cancer AJCC v8
  • Stage IV Primary Peritoneal Cancer AJCC v8
  • Stage IVA Fallopian Tube Cancer AJCC v8
  • Stage IVA Ovarian Cancer AJCC v8
  • Stage IVA Primary Peritoneal Cancer AJCC v8
  • Stage IVB Fallopian Tube Cancer AJCC v8
  • Stage IVB Ovarian Cancer AJCC v8
  • Stage IVB Primary Peritoneal Cancer AJCC v8
Intervention  ICMJE Biological: PRGN-3005 UltraCAR-T cells
Given IP or IV
Study Arms  ICMJE Experimental: Treatment (PRGN-3005 UltraCAR-T cells)
Patients receive autologous PRGN-3005 UltraCAR-T cells IP or IV.
Intervention: Biological: PRGN-3005 UltraCAR-T cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 5, 2019)
41
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2026
Estimated Primary Completion Date April 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosed with recurrent, advanced, platinum resistant ovarian, fallopian tube, and primary peritoneal cancer that have progressed after receiving standard of care therapies or are not eligible to receive available therapies with known clinical benefit will be eligible for the study. Patients must have measurable disease that can be accurately measured in at least one dimension as >= 1.0 cm or > 1.5 cm lymph node with computed tomography (CT), ultrasound, or magnetic resonance imaging (MRI) techniques.

    • Platinum resistant is defined as progression of disease within six months of platinum regimen.
    • Patients with BRCA mutations who have completed standard therapies (including PARP inhibitors) are allowed on this study.
  • Patients must be capable of understanding and providing a written informed consent.
  • Patients must be of any race or ethnicity.
  • Patients at least 14 days from previous cytotoxic chemotherapy.
  • Laboratory values must indicate adequate organ function
  • Patients must be at least 28 days post systemic steroids prior to enrollment.
  • Patients must have Eastern Cooperative Oncology Group (ECOG) performance status score of =< 2.
  • Patients must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment.
  • Negative serum pregnancy test for women of childbearing potential. Women of childbearing potential are those who have not been surgically sterilized, are < 60 years old, or have had menses within the past 12 months.
  • Women of childbearing potential must be willing to use 2 methods of contraception before, during, and at least 4 months after the PRGN-3005 cell infusion.

Exclusion Criteria:

  • Patients with any of the following cardiac conditions:

    • Symptomatic restrictive cardiomyopathy
    • Unstable angina or symptomatic coronary artery disease within 4 months prior to enrollment
    • New York Heart Association functional class III-IV heart failure on active treatment
    • Symptomatic pericardial effusion
    • Congestive heart failure
    • Clinically significant hypotension.
  • Patients with CA 125 =< ULN during screening.
  • Patients with history of human immunodeficiency virus (HIV), West Nile, Zika, or active hepatitis B or C infections.
  • Patients with severe, symptomatic ascites requiring diuretics, regular paracentesis, or other invasive interventions.
  • Patients within 28 days of receiving another investigational agent.
  • Patients with pulmonary hypertension, pulmonary fibrosis, or restrictive lung disease, patients with baseline oxygen saturation on room air < 92%, forced expiratory volume in 1 second (FEV1) =< 50%, or diffusion capacity of the lung for carbon monoxide (DLco) (corrected) of < 40% will be excluded.
  • Women who are pregnant or breast feeding.
  • Patients with second malignancy within the last 5 years excluding basal carcinoma of the skin, squamous carcinoma of the skin, or in situ cervical dysplasia that has undergone curative therapy.
  • Patients with an active autoimmune disease requiring immunosuppressive therapy or uncontrolled with treatment.
  • Patients who are simultaneously enrolled in any other treatment study.
  • Clinical or radiological evidence of acute bowel obstruction within 30 days of enrollment.
  • Patients with known or treated brain metastases.
  • Patients with an active seizure disorder.
  • Any female patient who does not meet at least one of the following criteria will be considered to have reproductive potential:

    • Post-menopausal for at least 12 consecutive months (i.e., no menses), or
    • Undergone a sterilization procedure (hysterectomy, salpingectomy, or bilateral oophorectomy; tubal ligation is not considered a sterilization procedure). Pregnancy test for females of reproductive potential must be negative within 14 days before leukapheresis.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sasha Stanton 206-685-8849 sestant2@uw.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03907527
Other Study ID Numbers  ICMJE RG1004303
NCI-2019-01789 ( Registry Identifier: NCI / CTRP )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fred Hutchinson Cancer Research Center
Study Sponsor  ICMJE Fred Hutchinson Cancer Research Center
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Precigen, Inc
Investigators  ICMJE
Principal Investigator: Sasha Stanton Fred Hutch/University of Washington Cancer Consortium
PRS Account Fred Hutchinson Cancer Research Center
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP